G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, and Pepper Bio, the world’s first transomics drug
discovery and development company, announced a global licensing
agreement (excluding the Asia-Pacific region) for lerociclib for
all indications except for certain radioprotectant uses. As Pepper
Bio’s first in-licensed therapeutic, lerociclib is a potent and
selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).
The therapeutic has previously demonstrated impressive efficacy in
clinical studies across various cancer types, including two
completed Phase 3 clinical trials in HR+/Her2- metastatic breast
cancer.
Today, the most common type of liver cancer, hepatocellular
carcinoma (HCC), is the third leading cause of all cancer-related
deaths. Using Pepper Bio’s transomics platform, COMPASS, the
company was able to identify CDK4 and CDK6 as potentially important
targets in treating HCC. Pepper Bio then tested lerociclib in
preclinical models, which showed superior efficacy over standard of
care during and after dosing. With this in-licensing deal,
lerociclib will be Pepper Bio’s first therapeutic on its way to
Phase 2 clinical trials.
Pepper Bio’s platform, COMPASS, translates layers of biological
maps, including genomics (genes), transcriptomics (RNA), proteomics
(proteins), and phosphoproteomics (function of proteins), to offer
researchers a complete picture of how diseases impact biology.
Setting Pepper Bio apart from other drug discovery platforms is its
unprecedented ability to look at the real-time function of proteins
in a biological system, as opposed to the current methods of only
measuring the presence, type, and quantity of proteins. COMPASS
unveils the intricate functions of these proteins, which
significantly impact how drugs are built and developed.
"Liver cancer is a real and devastating diagnosis for hundreds
of thousands of patients each year. Adding lerociclib into our
pipeline is a significant step forward in our mission to find
treatments for untreatable diseases," said Jon Hu, Chief Executive
Officer and co-founder of Pepper Bio. “Lerociclib holds tremendous
promise as a cornerstone of our oncology portfolio, and we are
excited to leverage its potential to bring life-saving treatments
to those in need."
Pepper Bio will gain exclusive rights to develop, manufacture,
and commercialize lerociclib for all indications except for certain
radioprotectant uses in the US, Europe, Japan, and all other global
markets, excluding the Asia-Pacific region, which G1 has already
licensed to Genor Biopharma. G1 Therapeutics and Pepper Bio will
collaborate closely to ensure a seamless transition and advance the
development of lerociclib through clinical trials and regulatory
approval processes.
This news follows Pepper Bio's oversubscribed seed funding
round, led by NFX, Silverton Partners, Merck Digital Sciences
Studio, and others. Pepper Bio is now poised to initiate clinical
development programs for lerociclib, with the ultimate goal of
obtaining regulatory approvals and making lerociclib available to
patients as quickly as possible.
Under the terms of the agreement, G1 is expected to receive
upfront payments totaling mid-single-digit millions within 12
months and is eligible to receive a maximum of $135M upon
achievement of development and commercial milestones in up to three
indications. In addition, Pepper Bio will pay G1 a double-digit
royalty on aggregate annual net sales of lerociclib.
"Pepper Bio’s commitment to innovation makes them the right
partner for advancing lerociclib through the next stages of
clinical development,” said Jack Bailey, Chief Executive Officer of
G1 Therapeutics. “This agreement is consistent with our corporate
strategy to form partnerships that enable global access to our
promising oncology therapies; with Pepper Bio, we look forward to
the opportunity to realize the full therapeutic potential of
lerociclib across new oncology indications."
For more information about G1 Therapeutics, please visit
www.g1therapeutics.com. For more information about Pepper Bio and
its drug development pipeline, please visit pepper.bio
About LerociclibLerociclib is a differentiated
oral CDK4/6 inhibitor based on its unique attributes, including its
increased selectivity and potency for CDK 4 and CDK 6 and shorter
half-life. Preliminary clinical data in hormone receptor-positive,
HER2-negative (HR+, HER2-) breast cancer have demonstrated
proof-of-concept of the differentiated clinical profile of
continuously dosed lerociclib versus currently marketed CDK4/6
inhibitors, with improved tolerability and less neutropenia while
maintaining robust clinical activity. Lerociclib has been licensed
to Genor Biopharma in the Asia-Pacific region (excluding Japan) and
is under National Medical Products Administration review in China
for 1L and 2L HR+/HER2- breast cancer.
About Pepper BioPepper Bio is the world’s first
transomics drug discovery company, leveraging its proprietary
transomics database and analytics to identify promising
first-in-class therapies, rediscover new uses for existing
therapeutics, and rescue drugs in development on a path toward
failure. Founded in 2020 and based in Boston, Massachusetts, Pepper
Bio is led by co-founder and Chief Executive Officer, Jon Hu, and
co-founder and Chief Science Officer, Samantha Dale Strasser, Ph.D.
For more information about Pepper Bio and its drug development
pipeline, please visit pepper.bio.
About G1 TherapeuticsG1 Therapeutics, Inc. is a
commercial-stage oncology biopharmaceutical company whose mission
is to develop and deliver next-generation therapies that improve
the lives of those affected by cancer, including the Company’s
first commercial product, COSELA® (trilaciclib). The Company is
also evaluating therapies in combination with cytotoxic therapies
and/or immunotherapy in areas of high unmet need including
triple-negative breast cancer and extensive stage small cell lung
cancer. G1’s goal is to provide innovative therapeutic advances for
people living with cancer. G1 is based in Research Triangle Park,
N.C. For additional information, please visit
http://www.g1therapeutics.com and follow us on X (formerly known as
Twitter) @G1Therapeutics and LinkedIn.
G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and
the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
"may," "will," "expect," "plan," "anticipate," “could”, “believe,”
“goal”, “projections,” "estimate," "intend," “indicate,”
“potential,” “promising,” “opportunity,” “suggest,” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Forward-looking statements in
this press release include, but are not limited to, statements
regarding the anticipated benefits of the licensing agreement
between Pepper Bio and G1 Therapeutics, the potential of lerociclib
as a treatment for cancer, and the anticipated development and
commercialization plans for lerociclib, are based on the company’s
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Factors that may cause the company’s actual results
to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in the company’s
filings with the U.S. Securities and Exchange Commission,
including the "Risk Factors" sections contained therein and
include, but are not limited to, the Company’s dependence on the
commercial success of COSELA (trilaciclib); the development and
commercialization of new drug products is highly competitive; the
Company’s ability to complete clinical trials for, obtain approvals
for and commercialize any of its product candidates; the Company’s
initial success in ongoing clinical trials may not be indicative of
results obtained when these trials are completed or in later stage
trials; the inherent uncertainties associated with developing new
products or technologies and operating as a commercial-stage
company; chemotherapy shortages and market conditions. Our business
is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should
give careful consideration to these risks and uncertainties. Except
as required by law, the company assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Contact:
Pepper Bio Contact:Caitlin Brown Head of
Business Developmentpepperbio@vsc.co
G1 Therapeutics Contact Will
RobertsCommunications OfficerVice President, Investor Relations and
Corporate Communications(919) 907-1944
wroberts@g1therapeutics.com
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